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Kaletra Q&A

INDICATIONS AND USAGE

KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-infection.

Once-daily administration of KALETRA is not recommended in therapy-experienced patients.

When initiating treatment with KALETRA in therapy-naïve patients, it should be noted that the incidence of diarrhea was greater for KALETRA once-daily compared to KALETRA twice-daily in Study 418 (57% vs. 35% - events of all grades and probably or possibly related to drug; 16% vs. 5% - events of at least moderate severity and probably or possibly related to drug) (see CLINICAL PHARMACOLOGY, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION).

3 Includes lost to follow-up, patient's withdrawal, non-compliance, protocol violation and other reasons. Overall discontinuation through Week 48, including patients who discontinued subsequent to virologic failure, was 17% in the KALETRA arm and 24% in the nelfinavir arm.

Once-daily administration of KALETRA is not recommended in therapy-experienced patients.

Concomitant therapy: Efavirenz, nevirapine, amprenavir or nelfinavir

A dose increase of KALETRA to 533/133 mg (4 capsules or 6.5 mL) twice-daily taken with food is recommended when used in combination with efavirenz, nevirapine, amprenavir or nelfinavir (see CLINICAL PHARMACOLOGY– Drug-drug Interactions and/or PRECAUTIONS – Table 11).

KALETRA should not be administered as a once-daily regimen in combination with efavirenz, nevirapine, amprenavir or nelfinavir.

Pediatric Patients

In children 6 months to 12 years of age, the recommended dosage of KALETRA oral solution is 12/3 mg/kg for those 7 to < 15 kg and 10/2.5 mg/kg for those 15 to 40 kg (approximately equivalent to 230/57.5 mg/m2) twice-daily taken with food, up to a maximum dose of 400/100 mg in children > 40 kg (5.0 mL or 3 capsules) twice-daily. KALETRA once-daily has not been evaluated in pediatric patients. It is preferred that the prescriber calculate the appropriate milligram dose for each individual child ≤ 12 years old and determine the corresponding volume of solution or number of capsules. However, as an alternative, the following table contains dosing guidelines for KALETRA oral solution based on body weight. When possible, dose should be administered using a calibrated dosing syringe.

Weight (kg)

Dose (mg/kg)*

Volume of oral solution BID (80 mg lopinavir/20 mg ritonavir per mL)

* Dosing based on the lopinavir component of lopinavir/ritonavir solution (80 mg/20 mg per mL).

Without nevirapine, efavirenz or amprenavir

7 to < 15 kg

12 mg/kg BID

7 to 10 kg

1.25 mL

> 10 to < 15 kg

1.75 mL

15 to 40 kg

10 mg/kg BID

15 to 20 kg

2.25 mL

> 20 to 25 kg

2.75 mL

> 25 to 30 kg

3.5 mL

> 30 to 35 kg

4.0 mL

> 35 to 40 kg

4.75 mL

> 40 kg

Adult dose

5 mL (or 3 capsules)

Note: Use adult dosage recommendation for children > 12 years of age.

Concomitant Therapy: Efavirenz, nevirapine or amprenavir

A dose increase of KALETRA oral solution to 13/3.25 mg/kg for those 7 to < 15 kg and 11/2.75 mg/kg for those 15 to 45 kg (approximately equivalent to 300/75 mg/m2) twice-daily taken with food, up to a maximum dose of 533/133 mg in children > 45 kg twice-daily is recommended when used in combination with efavirenz, nevirapine or amprenavir in children 6 months to 12 years of age. The following table contains dosing guidelines for KALETRA oral solution based on body weight, when used in combination with efavirenz, nevirapine or amprenavir in children (see CLINICAL PHARMACOLOGY– Drug-drug Interactions and/or PRECAUTIONS – Table 11).

Weight (kg)

Dose (mg/kg)*

Volume of oral solution BID (80 mg lopinavir/20 mg ritonavir per mL)

* Dosing based on the lopinavir component of lopinavir/ritonavir solution (80 mg/20 mg per mL).

With nevirapine, efavirenz or amprenavir

7 to < 15 kg

13 mg/kg BID

7 to 10 kg

1.5 mL

> 10 to < 15 kg

2.0 mL

15 to 45 kg

11 mg/kg BID

15 to 20 kg

2.5 mL

> 20 to 25 kg

3.25 mL

> 25 to 30 kg

4.0 mL

> 30 to 35 kg

4.5 mL

> 35 to 40 kg

5.0 mL (or 3 capsules)

> 40 to 45 kg

5.75 mL

> 45 kg

Adult dose

6.5 mL (or 4 capsules)

Note: Use adult dosage recommendation for children > 12 years of age.

HOW SUPPLIED

KALETRA (lopinavir/ritonavir) capsules are orange soft gelatin capsules imprinted with the corporate Abbott“A” logo and the Abbo-Code PK. KALETRA is available as 133.3 mg lopinavir/33.3 mg ritonavir capsules in the following package sizes:

Bottles of 180 capsules each….…………… (NDC 0074-3959-77)

Recommended storage: Store KALETRA soft gelatin capsules at 36°F - 46°F (2°C - 8°C) until dispensed. Avoid exposure to excessive heat. For patient use, refrigerated KALETRA capsules remain stable until the expiration date printed on the label. If stored at room temperature up to 77°F (25°C), capsules should be used within 2 months.